Philippine COVID-19 Living Clinical Practice Guidelines Institute of Clinical Epidemiology, National Institutes of Health, UP Manila In cooperation with the Philippine Society for Microbiology and Infectious Diseases Funded by the DOH AHEAD Program through the PCHRD
EVIDENCE SUMMARY
Among health care workers how effective is the use of personal protective equipment in the wards, ICU, and emergency room in the prevention of COVID 19 infection? Evidence Reviewers: Germana Emerita V. Gregorio, MD, Rowena F. Genuino, MD, MSc, Howell Henrian G Bayona, MSc, CSP-PASP
PPE in Hospital
RECOMMENDATION We recommend the use of the following PPE: disposable hat, medical protective mask (N95 or higher standard), goggles or face shield (anti-fog), medical protective clothing, disposable gloves and disposable shoe covers or dedicated closed footwear as an effective intervention in the prevention of COVID-19 among health care workers in areas with possible direct patient
care of COVID-19 positive patients and aerosol generating procedures. (Moderate quality of evidence; Strong recommendation)
Consensus Issues Direct patient care1 is defined as hands on, face-to-face contact with patients for the purpose of diagnosis, treatment and monitoring. This recommendation was made by the panel as it prioritized giving the best available protection to the healthcare workers. Whenever possible, hospital administrators should invest in these PPEs. Strict adherence to the appropriate use of PPEs must be observed even if healthcare workers have already been vaccinated against COVID-19.
1National Center for Emerging, Zoonotic and Infectious Diseases- Division of Healthcare Quality Promotion. (2020). The National Healthcare Safety Network (NHSN) Manual- Healthcare Personnel Safety Component Protocol: Healthcare Personnel Exposure Module. Atlanta, GA, USA: CDC.
PPE in Hospital As of 17 April 2021 Philippine COVID-19 Living Clinical Practice Guidelines
Key Findings Three studies and a case report were found on the use of PPE among health care workers to prevent COVID infection. Moderate certainty evidence from three studies showed that the use of Level 2 PPE (disposable hat, medical protective mask (N95 or higher standard), goggles (anti-fog) or protective mask (anti-fog), medical gown clothing or white coats covered by medical protective clothing, disposable gloves and disposable shoe covers), N95 respirators and face shields protected health care workers in hospital settings from COVID-19 infections. On the other hand, very low certainty evidence showed no significant protective effect from the use of face/surgical masks, gowns, and/or disposable gloves if used individually.
Introduction The COVID-19 pandemic has placed the health care workers (HCW) at high risk of infection. The use of personal protective equipment (PPE) has been shown to be effective in preventing infection against related betacoronaviruses that have caused epidemics, such as severe acute respiratory syndrome (SARS) or Middle East respiratory syndrome (MERS) [1,2]. PPE use depends on the risk of exposure, availability, and environmental control. The evidence on PPE recommendations, including the use of face mask, face shield, gowns and gloves, to prevent COVID 19 infection among health care workers are limited.
Review Methods We searched MEDLINE, Cochrane CENTRAL, ChinaXiv, MedRXIV, BioRXIV and ongoing and completed trials on USA: https://clinicaltrials.gov/; China: http://www.chictr.org.cn/searchprojen.aspx and WHO: https://www.who.int/clinical-trials-registry- platform. We also searched for published/ongoing studies on the COVID-19 Open Living Evidence Synthesis: https://covid-nma.com/ and the Living Evidence on COVID-19: https://zika.ispm.unibe.ch/assets/data/pub/search_beta/. The initial search date was 31 March 2021 (updated 30 April 2021).
The following keywords were used: ‘covid’, ‘COVID-19’, ‘coronavirus’, ‘SARS-CoV-2’, ‘viral’, ‘infection’, ‘respiratory’ ‘respirator’, ‘surgical mask’, ‘N95 mask’, ‘PPE’, ‘personal protective equipment’, ‘face shield’, ‘googles’, ‘eye protector’, ‘gown’, ‘gloves’, ‘health care worker’, ‘COVID- 19’, ‘coronavirus’, ‘SARS-CoV-2’. Subject headings and free text were combined 1. We included experimental or observational studies, meta-analysis/systematic reviews, completed trials and/or preprints that investigated the efficacy of PPE in preventing COVID 19 infection among health care workers in non-surgical areas (wards, ICU, emergency room). Two reviewers appraised the methodological quality of included studies using the Newcastle Ottawa Scale. We used the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach to assess the certainty of the evidence related to the outcomes.
1 ((((((((((COVID 19[MeSH Terms]) AND health care w orkers (personal protective equipment[MeSH Terms])) OR (face mask[MeSH Terms])) OR (surgical mask[MeSH Terms])) OR (respirators[MeSH Terms])) OR (goggles[MeSH Terms])) OR (face shield[MeSH Terms])) OR (eye protector[MeSH Terms])) OR (gow ns, surgical[MeSH Terms])) OR (gloves, surgical[MeSH Terms]))) AND (health care w orker[MeSH Terms])
PPE in Hospital As of 17 April 2021 Philippine COVID-19 Living Clinical Practice Guidelines
Results Characteristics of included studies Four observational studies (cohort, case control and cross sectional) and a case report were included. Two of these studies were also found in two systematic reviews [1,2] that reported on the association of COVID 19 infection with the use of PPE. Only data relevant to health workers in these studies were considered. Population of the studies were on health care workers mostly employed in health care facilities that attend to patients with COVID 19. Information on the various PPEs that were used by the health care workers while working in the health care facilities was gathered and their association with COVID 19 infection were assessed. Refer to Appendix 1 for detailed characteristics of these included studies.
Methodological quality Four studies, two cohort [3,4], a case control [5] and a cross sectional [6], were assessed as having low quality and a case report [7] as very low quality The studies were direct evidence and with no inconsistencies, however with high risk of bias. For the three observational studies, two used a structured questionnaire [3] [6]and one reviewed infectious records [5] to gather data and thus subject to recall and information bias. Another study [4] was a surveillance data of COVID positive HCW before and after the implementation of the use of face shield. For the protective effect of the use of face shield in two studies [4] [6], confounders in the assessment could be its use together with the standard PPE, compliance of HCW on properly wearing it and in other preventive measures and the type of work done whether or not it is an aerosol generating procedure.
Level 2 Protection Moderate quality evidence from a retrospective cohort study by Wang et al. [3] showed the protective effect of Level 2 protection among 5442 medical staff of Neurosurgery Departments of 107 hospitals in Hubei China (OR 0.03 [95% CI 0, 0.19]). Of the 120 who were infected , 54 were neurosurgeons and 66 were nurses involved with COVID 19 patients with patient contact time between 5 to 90 minutes (average time: 35 minutes) Level 2 in their center involved the use of the following: disposable hat, medical protective mask (N95 or higher standard), goggles (anti-fog) or protective mask (anti-fog), medical gown clothing or white coats covered by medical protective clothing, disposable gloves and disposable shoe covers.
Additional data from a cross sectional study in Bangladesh involving 190 HCW in 19 health facilities [6], a possible protective effect in using PPE was reported (OR 0.15 [95% CI 0.02, 1.21]). The evidence was downgraded due to imprecision. However, the type of PPE used in this study was not specified; thus, this was not included in the analysis.
N95 respirators Moderate certainty evidence involving 493 participants demonstrated a protective effect with the use of N95 respirators (OR: 0.035 [95% CI 0.002 to 0.603]). This was a case control study in Wuhan China [5] but was assessed as to have a large effect. Another study [6] from Bangladesh involving 190 health workers also demonstrated the N95 protective effect during aerosol generating procedure (OR 0.37 [95% CI 0.16-0.87]).
PPE in Hospital As of 17 April 2021 Philippine COVID-19 Living Clinical Practice Guidelines
Face mask In the cross-sectional study in Bangladesh [6], very low certainty evidence suggested that the use of medical/surgical masks while attending to COVID 19 patients was not associated with infection among 190 health workers (OR 1.40 [95% CI 0.30, 6.42]) [5]. The evidence was downg raded as very low due to imprecision. The study used a structured questionnaire which was answered by the participants and therefore subject to recall bias. A case report [6], however, showed that among 37 health care workers who were exposed to a COVID-19 patient, 3/34 (8.8%) who did not wear a mask were infected while none of the three who were wearing a mask were infected.
Face shield Moderate certainty evidence [4] before and after face shield use was implemented demonstrated the protective effect of face shield with standard PPE among 6527 health care personnel (HCP) who were tested for COVID. (RR 0.297 [95% CI 0.228, 0.385]). The type of PPE used was not discussed. The data was from a surveillance study in a quarternary health care system in Texas. Biweekly testing for HCP in high-risk units (emergency department, transplant units and COVID- 19 units) and weekly testing for HCP in cluster areas (>= 3 cases of HCP with COVID-19 diagnosis or any case of hospital-acquired infection) were done. Testing was voluntary for HCP and HCP in other areas if they desire or if with exposure history. HCP with previous positive COVID-19 diagnosis were excluded. This was a cohort study and was initially graded as low but was upgraded due to the large effect.
A cross sectional study [6] showed that using face shield/googles when attending to COVID-19 patients was protective for health care workers (OR 0.44 [95% CI 0.23, 0.843]). The evidence was downgraded to very low as the study used a structured questionnaire which may have increased risk of recall bias. In both studies cited, confounders in the assessment of the protective effect of face shield may be present as cited in the methodological quality.
Disposable gowns/gloves No significant difference in the incidence of COVID infection was observed among 190 health care workers who used disposable gowns (OR 1.08 [95% CI 0.53, 2.20]) and disposable gloves (OR 1.01 [95% CI 0.38, 2.68]) while caring for infected patients [6]. For aerosol-generating procedures, no benefit was also noted for gowns (OR 0.77 [95% 0.31, 1.88)] and gloves (OR 0.62 [95% CI 0.13, 2.90]). This effect was based on very low-quality evidence from one study [5]. The evidence was downgraded due to imprecision and risk of bias with use of a structured questionnaire subject to recall bias.
Recommendations from Other Groups The table below provides a summary of PPE recommendations from four different health agencies. [8] PPE recommendations across countries differ in terms of setting, type of personnel, and activity.
PPE in Hospital As of 17 April 2021 Philippine COVID-19 Living Clinical Practice Guidelines
World Health Organization (19 March 2020) [9] stated that the types of PPE to be used when caring for COVID-19 patients will vary according to the setting and type of personnel and activity. Healthcare workers involved in the direct care of patients should use the following PPE: gowns, gloves, medical masks, and eye protection (goggles or face shield). For aerosol-generating procedures (e.g., tracheal intubation, non-invasive ventilation, tracheostomy, cardiopulmonary resuscitation, manual ventilation before intubation, bronchoscopy) healthcare workers should use respirators, eye protection, gloves, and gowns; aprons should also be used if gowns are not fluid resistant.
The European Center for Disease Control (9 Feb 2021) [10] recommends healthcare workers in contact with a possible or confirmed COVID-19 case to wear a well-fitted respirator, eye protection (i.e., visor or goggles), gloves, and a long-sleeved gown if there is risk for contact with body fluids and in settings where contamination is presumably high, such as where aerosol generating procedures are performed. Aprons can be used in place of gowns, if contact with body fluids is low. Gloves and the gown or apron should be changed between patient contacts.
The Australia Department of Health (09 Nov 2020) [11] included the following in the routine care of patients with suspected or confirmed COVID-19: surgical mask or particulate filter masks (P2 or N95 masks) depending on risk of blood body fluid, long sleeves gown / aprons, eye protection, face shield, wrap-around safety glasses/visor /goggles, and disposable non sterile gloves. Head cover and boots or shoe covers is not recommended unless gross contamination is anticipated or they are required as standard attire in operating theatre or trauma room.
PPE in Hospital As of 17 April 2021 Philippine COVID-19 Living Clinical Practice Guidelines
The US Centers for Disease Control (23 Feb 2021) [12] had recommendations similar to the Australian Department of Health which included N95 or higher respirators (If not available, use face mask), face shield/googles, clean non-sterile gloves and isolation gown.
Research Gaps Based on clinicaltrials.gov, there is one completed trial on the use of PPE in health care workers (completed January 2021) and one ongoing trial on with or without PPE during neonatal resuscitation.
References [1] Chu DK, Akl EA, Duda S, Solo K, Yaacoub S, Schünemann HJ; COVID-19 Systematic Urgent Review Group Effort (SURGE) study authors. Physical distancing, face masks, and eye protection to prevent person-to-person transmission of SARS-CoV-2 and COVID-19: a systematic review and meta-analysis. Lancet. 2020 Jun 27;395(10242):1973-1987. doi: 10.1016/S0140-6736(20)31142-9. Epub 2020 Jun 1. PMID: 32497510; PMCID: PMC7263814 [2] Tabatabaeizadeh SA. Airborne transmission of COVID-19 and the role of face mask to prevent it: a systematic review and meta-analysis. Eur J Med Res. 2021 Jan 2;26(1):1. doi: 10.1186/s40001-020-00475-6. PMID: 33388089; PMCID: PMC7776300. [3] Wang Q, Huang X, Bai Y, et al. Epidemiological characteristics of COVID-19 in medical staff members of neurosurgery departments in Hubei province: a multicentre descriptive study. medRxiv 2020; published online April 24. DOI:10.1101/2020.04.20.20064899 (preprint). [4] Al Mohajer M, Panthagani KM, Lasco T, Lembcke B, Hemmige V. Association between universal face shield in a quaternary care center and reduction of SARS-COV2 infections among healthcare personnel and hospitalized patients. Int J Infect Dis. 2021 Apr; 105:252-255. doi: 10.1016/j.ijid.2021.02.060. Epub 2021 Feb 18. PMID: 33610788; PMCID: PMC7891045. [5] Wang X, Pan Z, Cheng Z. Association between 2019-nCoV transmission and N95 respirator use. J Hosp Infect 2020; May;105(1):104-105. doi: 10.1016/j.jhin.2020.02.021. Epub 2020 Mar 3. PMID: 32142885; PMCID: PMC7134426. [6] Khalil MM, Alam MM, Arefin MK, Chowdhury MR, Huq MR, Chowdhury JA, Khan AM. Role of Personal Protective Measures in Prevention of COVID-19 Spread Among Physicians in Bangladesh: a Multicenter Cross-Sectional Comparative Study. SN Compr Clin Med. 2020 Aug 28:1-7. doi: 10.1007/s42399-020-00471-1. Epub ahead of print. PMID: 32904377; PMCID: PMC7454131. [7] Heinzerling A, Stuckey MJ, Scheuer T, Xu K, Perkins KM, Resseger H, Magill S, Verani JR, Jain S, Acosta M, Epson E. Transmission of COVID-19 to Health Care Personnel During Exposures to a Hospitalized Patient - Solano County, California, February 2020. MMWR Morb Mortal Wkly Rep. 2020 Apr 17;69(15):472-476. doi: 10.15585/mmwr.mm6915e5. PMID: 32298249; PMCID: PMC7755059. [8] Park SH. Personal Protective Equipment for Healthcare Workers during the COVID-19 Pandemic. Infect Chemother. 2020 Jun;52(2):165-182. doi: 10.3947/ic.2020.52.2.165. PMID: 32618146; PMCID: PMC7335655.
PPE in Hospital As of 17 April 2021 Philippine COVID-19 Living Clinical Practice Guidelines
[9] World Health Organization. (2020, March 19). Rational use of personal protective equipment (PPE) for coronavirus disease (COVID-19) . Retrieved from World Health Organization: https://apps.who.int/iris/bitstream/handle/10665/331498/WHO-2019- nCoV-IPCPPE_use-2020.2-eng.pdf [10] European Centre for Disease Prevention and Control. Infection prevention and control and preparedness for COVID-19 in healthcare settings – Sixth update. 9 February 2021. ECDC: Stockholm; 2021. [11] Infection Control Expert Group (ICEG). (2020, November 9). Guidance on the minimum recommendations for the use of personal protective equipment (PPE) in hospitals during the COVID-19 outbreak . Retrieved from Australian Government- Department of Health: https://www.health.gov.au/sites/default/files/documents/2020/11/guidance-on- the-use-of-personal-protective-equipment-ppe-in-hospitals-during-the-covid-19- outbreak.pdf [12] National Center for Immunization and Respiratory Diseases (NCIRD), Division of Viral Diseases. (2021, February 23). Interim Infection Prevention and Control Recommendations for Healthcare Personnel During the Coronavirus Disease 2019 (COVID-19) Pandemic. Retrieved from Centers for Disease Control and Prevention: https://www.cdc.gov/coronavirus/2019-ncov/hcp/infection-control- recommendations.html
PPE in Hospital As of 17 April 2021 Philippine COVID-19 Living Clinical Practice Guidelines
Appendix 1. Characteristics of Included studies
Setting Population Intervention Comparator Outcome Wang Q Hubei China 5442 medical staff of 107 Adequate Level 2 Inadequate PPE Number of HCW infected Neurosurgery Departments PPE1 and not infected with COVID 19 Wang X Wuhan 493 Medical staff of With N95 respirator No N95 respirators Number of HCW infected China and not infected with Zhongnan Hospital COVID 19 Khalil SN Dhaka 190 Medical staff in 19 health Face mask Number of HCW with face Bangladesh facilities mask infected with COVID 19 Face shield Number of HCW with face shield infected with COVID 19 PPE Number of HCW with PPE infected with COVID 19 Gloves Number of HCW with gloves infected with COVID 19 N95 Number of HCW with N95 respirator infected with COVID 19 Mojajer A Houston 6527 Health Care Personnel of Face shield2 with Standard PPE Number of HCP infected Texas a quarternary health hospital standard PPE before and after implementation of use of face shield with standard PPE
PPE in Hospital As of 17 April 2021 Philippine COVID-19 Living Clinical Practice Guidelines
Number of HCP with HAI before and after implementation of use of face shield with standard PPE Heinzerlin Solano 37 Medical staff exposed to Face mask Number of HCW with face g A California Index patient mask infected with COVID 19 Gloves Number of HCW wearing gloves infected with COVID 19 1 Adequate PPE: disposable hat, medical protective mask (N95 or higher standard), goggles (anti-fog) or protective mask (anti-fog), medical gown clothing or white coats covered by medical protective clothing, disposable gloves and disposable shoe covers. 2 Face shield used was a Lazarus 3D (Corvallis, OR, USA) 3 Abbreviations: HCW: health care worker; HCP: health care personnel
PPE in Hospitals As of 17 April 2021 Philippine COVID-19 Living Clinical Practice Guidelines
Appendix 2. GRADE Evidence Profile
PPE Level 2 compared to No PPE Level 2 in prevention of COVID 19 infection in health care workers
Certainty assessment Summary of findings
Participants Overall Study event rates (%) Anticipated absolute effects Risk of Relative effect (studies) Inconsistency Indirectness Imprecision Publication bias certainty of bias With No PPE With PPE (95% CI) Risk with No Risk difference Follow up evidence Level 2 Level 2 PPE Level 2 with PPE Level 2 COVID infection (assessed with: RT PCR)
a 5442 not not serious not serious serious strong association ⨁⨁⨁◯ 119/4155 1/1287 (0.1%) RR 36.9 29 per 1,000 1,000 more per (1 serious all plausible MODERATE (2.9%) (5.2 to 263.6) 1,000 observational residual (from 120 more to study) confounding 1,000 more) would reduce the demonstrated effect CI: Confidence interval; RR: Risk ratio Explanations a. Wide confidence interval
N95 respirators compared to no N95 respirators for prevention of COVID 19 infection in health care workers
Certainty assessment Summary of findings Study event rates (%) Anticipated absolute effects Participants Overall Risk of Relative effect Risk with no Risk difference (studies) Inconsistency Indirectness Imprecision Publication bias certainty of With no N95 With N95 bias (95% CI) N95 with N95 Follow up evidence respirators respirators respirators respirators N95 respirators vs no N95 respirators in prevention of COVID 19 INFECTION
10 cases 483 not not serious not serious not serious strong association ⨁⨁⨁◯ 10 cases 483 controls OR 0.035 Moderate controls serious (0.002 to 0.603) MODERATE 0 per 1,000 0 fewer per 1,000 (1 observational (from 0 fewer to 0 fewer) study) CI: Confidence interval; OR: Odds ratio
PPE in Hospitals As of 17 April 2021 Philippine COVID-19 Living Clinical Practice Guidelines
Face Shield compared to No Face Shield for prevention of COVID 19 infection in health care workers
Certainty assessment Summary of findings Anticipated absolute Study event rates (%) effects Participants Relative Risk of Overall certainty Risk (studies) Inconsistency Indirectness Imprecision Publication bias effect Risk with bias of evidence With No With Face difference Follow up (95% CI) No Face Face Shield Shield with Face Shield Shield Face shield vs no face shield in the prevention of COVID 19 infection
a 6527 serious not serious not serious not serious strong ⨁⨁⨁◯ 166/2486 80/4041 RR 0.297 67 per 47 fewer per (1 observational association MODERATE (6.7%) (2.0%) (0.228 to 1,000 1,000 study) all plausible 0.385) (from 52 fewer residual to 41 fewer) confounding would suggest spurious effect, while no effect was observed CI: Confidence interval; RR: Risk ratio Explanations a. Protective effect of face shield may be compounded by its use with standard PPE, compliance of health care personnel on its use and other preventive measures and the type of work that is done
PPE in Hospitals As of 17 April 2021 Philippine COVID-19 Living Clinical Practice Guidelines
Appendix Table 3. Characteristics of ongoing clinical trials
No Clinical Trial Study design, Population Intervention Comparison Outcomes . ID / Title status Group(s) Group(s) 1 NCT047120 Interventional Health care New PPE: Old PPE Primary outcome: 45 clinical trial, workers Level 2 PPE Level 2 Proportion of participants and simulated patients with completed (UK) which PPE which contamination as assessed by ultraviolet light (15 Jan 2021) involves involves Rational Secondary Outcome: wearing a wearing a Use of short-sleeve long-sleeve 1. Participants' perception of personal comfort Personal gown and a gown and and safety and safety of the patients as Protective single pair of double pairs assessed through structured questionnaire Equipment: gloves of gloves [Time Frame: immediately before simulations a and immediately after simulations] Randomised 2. Changes in participants perception of personal Trial and comfort and safety and safety of patients as Quality assessed through a semi-structured Improvemen questionnaire [Time Frame: immediately t before training, immediately after training and Intervention immediately after simulation] During 3. The difference in the area of contamination COVID-19 between New and Standard PPE as analyzed through python script Pandemic [Time Frame: immediately after simulations] 2 NCT046662 Randomized Health care With PPE Without Primary Outcome: 33 open label trial, workers PPE not yet (Padova, recruiting Italy) Initiation of positive pressure ventilation [Time Frame: 5 minutes]
(no date)
PPE in Hospitals As of 17 April 2021 Philippine COVID-19 Living Clinical Practice Guidelines
Personal Secondary Outcome: Protective 1. Duration of intubation procedure [Time Frame: Equipment 5 minutes for the 2. Correct use of personal protective equipment Prevention [Time Frame: 20 minutes] of SARS- 3. Participant's opinion on discomfort using Cov-2 personal protective equipment [Time Frame: 20 During minutes Level of discomfort in performing the Neonatal procedures: 0 (no discomfort), 1 (low Resuscitatio discomfort) ,2 (high discomfort) n 4. Time of initiation of chest compressions [Time Frame: 20 minutes]
PPE in Hospitals As of 17 April 2021